112594 - Clinical Research and Regulatory Coordinator
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#112594 Clinical Research and Regulatory CoordinatorExtended Review Date: Fri 11/19/2021
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 10/29/2021 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/9/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Moores Cancer Center is one of just 51 in the United States to hold a National Cancer Institute (NCI) designation as a Comprehensive Cancer Center. As such, it ranks among the top centers in the nation conducting basic and clinical cancer research, providing advanced patient care and serving the community through outreach and education programs. The Cancer Center's mission is to translate promising scientific discoveries into new and better options for the care of patients with cancer. The Center supports one of the broadest ranges of cancer activities in the nation - from fundamental and translational cancer research in molecular genetics and advanced molecular therapeutics, and from population studies of cancer incidence to community education about cancer prevention and risk reduction.
The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.
Reporting directly to the Disease Team Project Manager, the Clinical Research and Regulatory Coordinator coordinates the clinical research efforts of the Moores UCSD Cancer Center Clinical Trials Office (CTO). The incumbent is responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. They are also responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center. The key to this role is the preparation of clinical trial protocols and related regulatory documents for submission to the UCSD Human Research Protections Program (UCSD's Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed. They will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, UCSD IRB, and the CTO. This position requires regular interaction with a variety of internal and external contacts including Cancer Center investigators and staff, UCSD IRB staff, study sponsors and/or their representatives. They directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards. They will provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing. Other duties assigned as needed.
Theoretical knowledge of biology, microbiology, social sciences, clinical sciences and/or Bachelor's degree, and/or an equivalent combination of education and experience.
Experience performing clinical research duties in a clinical research environment. Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Experience in medical assessment, patient interviewing, and interpreting laboratory procedures and values to determine toxicities and patient eligibility related to protocol management.
Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines.
Experience preparing various forms, documents, and reports, such as New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments.
Experience creating Informed Consent Documents that comply with HRPP/UCSD IRB policies and procedures, FDA regulations, and sponsor requirements.
Experience interpreting medical charts and abstracting data from medical records in relation to study subject screening.
Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word as well as experience completing clinical trials case report forms via hard copy and online.
Experience providing in-service training to various research personnel on protocols, processes, and procedures.
Experience with editing, including summarizing information into concise and condense documents.
Skill in working independently and following through on assignments with minimal supervision. Good judgement to know when to ask for assistance from supervisor in cases where regulations and policies & procedures are not clear.
Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.
Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.
Ability to work independently. Ability to maintain confidentiality.
Demonstrated ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others.
Demonstrated knowledge or demonstrated related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.
Proven ability to determine sources of information and data, and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological approach to problem solving.
- Knowledge of hematology/oncology. Ability to differentiate various cancers by stage, histology, and site to determine patient eligibility for protocols and assure accurate randomization.
Employment is subject to a criminal background check and pre-employment physical.
Must be able to obtain annual TB/Fit test clearances.
Must be able to travel to different locations and work weekends and evenings as needed.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html
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